Pluvicto Poised to Lead Booming Radioligand Therapy Market for Prostate Cancer

According to the Zhitong Finance APP, the market for radioligand therapy (RLT) is expected to achieve significant growth by 2030. Pluvicto, an RLT product from Novartis (NVS.US), is likely to capture the largest share in the prostate cancer therapy field.

Prostate cancer is the most commonly diagnosed cancer among men in more than half of all countries worldwide. The incidence and mortality rates of prostate cancer remain high. According to The Lancet's major report on prostate cancer, the number of global prostate cancer cases is projected to increase from 1.4 million per year in 2020 to 2.9 million per year by 2040, doubling the number of patients; the largest increase will occur in low- and middle-income countries. Additionally, the number of men dying from prostate cancer annually is expected to rise from 375,000 in 2020 to nearly 700,000 by 2040, marking an increase of approximately 85%.

RLT Therapy: A New Approach to Cancer TreatmentRLT therapy is a novel method for treating cancer. This therapy uses specific molecules combined with radionuclides to precisely target tumor lesions and utilizes radiation to kill target cells. In recent years, innovative radioligand therapies (RLT) represented by lutetium-177 have become a focal point in the field of prostate cancer diagnosis and treatment. This therapy has confirmed its efficacy and safety in the treatment of gastroenteropancreatic neuroendocrine tumors and prostate cancer, particularly showing a significant improvement in survival rates for patients with advanced metastatic prostate cancer.

According to GlobalData, Pluvicto (177Lu-PSMA-617), which received U.S. Food and Drug Administration (FDA) approval in 2022, is rapidly becoming a mainstream RLT product for prostate cancer. In 2023, Pluvicto achieved $980 million in sales revenue with a 260% increase, just one step away from becoming a blockbuster drug worth $1 billion. By 2024, Pluvicto's sales revenue is expected to soar to over $1.5 billion and will further reach approximately $4.3 billion by 2030.

Although Pluvicto is not the first RLT therapy approved for prostate cancer — Bayer's Xofigo (radium-223 dichloride) was approved in the U.S. in 2013 — the revenue of Xofigo pales in comparison to that of Pluvicto. GlobalData predicts that Xofigo’s sales revenue will be only $244 million in 2024, dropping to $161 million by 2030. However, in May 2023, Bayer partnered with Bicycle Therapeutics (BCYC.US) to develop new radiopharmaceuticals, which are expected to provide more RLT therapies in the future.

GlobalData’s oncology and hematology analyst Thomas Wales stated that the strong trial results of Pluvicto will drive its growth. Pluvicto was approved by the FDA for marketing in March 2022, indicated for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitors (APRI) and taxane chemotherapy. The approval of Pluvicto was based on a pivotal Phase III clinical trial (VISION), which showed that adding Pluvicto to the standard treatment for advanced PSMA-positive mCRPC significantly extended radiographic progression-free survival (rPFS, 8.7 vs 3.4 months) and overall survival (OS, 15.3 vs 11.3 months).

Thomas Wales added that Novartis has recently submitted an application to expand the indications of Pluvicto to patients who have not yet received paclitaxel chemotherapy. If the application is approved, it will expand the potential patient market.

Other RLT therapies for prostate cancer developed by pharmaceutical companies are also expected to enter the market in the coming years, including Eli Lilly's (LLY.US) lutetium (lutetium Lu 177 dotatate), which is not expected to gain approval until 2025. GlobalData predicts that lutetium will generate revenue of only $125 million in 2025, increasing to $1.65 billion by 2030. Additionally, in 2023, Eli Lilly acquired radiopharmaceutical company POINT BioPharma for $1.4 billion. The latter is developing RLT therapies at clinical and preclinical stages for cancer treatment.

AstraZeneca (AZN.US) Acquires Prostate Cancer RLT Candidate FPI-2265-202 Through $2.4 Billion Purchase of Fusion Pharma, Completed Earlier in 2024. Despite the Phase 2/3 trial plan for PSMA-positive mCRPC patients expected to conclude in 2026, GlobalData anticipates the therapy will gain approval in 2028, with sales revenue reaching only $182 million by 2030.